Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01756014
Other study ID # BRAIN-HF
Secondary ID
Status Recruiting
Phase N/A
First received December 19, 2012
Last updated December 21, 2012
Start date January 2012

Study information

Verified date December 2012
Source University Medical Center Groningen
Contact Adriaan A Voors, MD/PhD
Phone +31 50 3612355
Email a.a.voors@umcg.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The investigators will evaluate the determinants of cerebral impairment in patients with non-ischemic heart failure compared to controls, and its relation to cognitive function. They hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic factors are associated with cognitive dysfunction.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria Control Group:

- Healthy subject, as assessed by clinician

- Age matched with patient group

Exclusion Criteria Control Group:

- Age < 18 years

- Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis > 50%)

- Unable or unwilling to undergo MRI

- The presence of ferromagnetic material in or on the body, for example tattoos with ferrous ink or pacemakers or cardiac defibrillators. Also the presence of pregnancy and claustrophobia.

- History of cognitive impairment

- Unable to understand procedures

- Unable or unwilling to provide informed consent

Inclusion Criteria DCM-group:

- Heart failure due to DCM

- 15 patients with NYHA class II

- 15 patients with NYHA class III/IV

Exclusion Criteria DCM-Group:

- Age < 18 years

- History of myocardial infarction

- History of peripheral artery disease

- History of cerebrovascular disease or

- Carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis > 50%)

- History of cognitive impairment

- Unable to undergo MRI (eg pacemaker)

- Unable to understand procedures

- Unable or unwilling to provide informed consent

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Netherlands University Medical Centre Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determinants of cerebral impairment Determinants of cerebral impairment in patients with heart failure compared to controls, where cerebral impairment is defined as decreased cognitive function and cerebral hypoperfusion Baseline No
Secondary Prevalence of cognitive impairment Prevalence of cognitive impairment in patients with heart failure Baseline No
Secondary Relation of cognitive impairment with local perfusion Relation of cognitive impairment with perfusion of carotid artery territory and basilar artery territory Baseline No
Secondary Relation of cognitive impairment with the severity of heart failure Relation of cognitive impairment with the severity of heart failure Baseline No
Secondary Relation of cognitive impairment with cardiac output Relation of cognitive impairment with cardiac output Baseline No
Secondary Relation of cognitive impairment with the severity of congestion Relation of cognitive impairment with the severity of congestion Baseline No
Secondary Relation of cognitive impairment with the decrease in cerebral perfusion Relation of cognitive impairment with the decrease in cerebral perfusion Baseline No
Secondary The difference of cognitive domains in above relations The difference of cognitive domains in above relations Baseline No
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy